Denner needs to know he has the votes. I think he does based on management doing their best to bury the election results so far. Pathetic.

Once he has the votes he will act and the fireworks begin. I would be surprised if he waited until August as most of the institutional investors he will be calling on to support him will be on the beach in the Hamptons.

Strongly doubt he takes his marbles and goes home. Not his playbook.

CVD increases over time as patients age. Especially true of diabetics which I will bet were a significant number of patients in this study. Looking at CR-P there is good literature that shows it worsens over time in patients that have CVD. Age alone increases LDL. If Vascepa stabilized these biomarkers then you are seeing a biological effect of the drug.

Ultimately biomarkers are only a rough approximation, in the case of trigs actually meaningless, and what you really care about is plaque formation and its composition. IMO Evaporate is really the vital mechanistic study that slammed the door on the mineral oil nonsense.

"It has been suggested that the mineral oil placebo used in both EVAPORATE and REDUCE-IT may have modestly inhibited the benefits of statin therapy in the placebo group since the hsCRP values and LDL-values increased. This was addressed by the EVAPORATE investigators, who performed an additional investigation comparing the rates of plaque progression among individuals administered the same mineral oil placebo as the clinical trials compared to a cellulose-based placebo; they found no difference in the progression of plaque between the two forms of placebo."

As Kiwi noted, if Mitigate has positive results that should be the end of this idiocy.

Z totally correct

I will ask the same question that I asked several months ago: Is anyone making real money on Vascepa in the US? The generics have not followed the only game plan they know, sell in a fully mature market with millions of legacy patients. Teva understood this would fail hence staying on the sidelines.

One strategy would be to cut a deal with them. They stay out of the US for X # of years. Amarin does a an HLS/Pfizer in the US (no GIA please) which will actually get Vascepa to patients and might even move the SP. A real BOD and CEO would consider strategies other than drive the company into the ground. Sarissa certainly will.

The overall pie is shrinking for everyone. MD's are not writing the RXs and even many cardiologists have no idea what Vascepa is. Shockingly Lovaza is still winning the new Rx sweepstakes.

Pathetic

I strongly suspect that Sarissa would not have invested so significantly in Amarin if they did not use Dr. Denner's rolodex and take the temperature of multiple BP's regarding Vascepa before jumping in the deep side of the pool.

Time will tell, but clearly we are in a new era and hopefully this drug will eventually reach its full potential. Sarissa of course expects a huge ROI, but a secondary benefit will be finally unleashing Vascepa's potential for a multitude of diseases.

And for us tormented longs, finally a ray of light....

Rose you nailed it.

Ignoring the US and concentrating on Europe has enormous value IF THEY CAN EXECUTE. To date that has not happened anywhere and the Street thinks management was duplicitous last earnings and appropriately punished the stock price. Sarissa was probably also caught off guard and has serious reservations about management and BOD.

KM and BOD should be welcoming Sarissa with a parade as this is will be the only avenue of creating any shareholder value going forward. If Denner goes full hostile this week (I suspect he will) than those on this board who believe that management have used AMRN as a piggy bank will be proven correct.

At the current SP a previous poster noted the possibility of Sarissa just taking Amarin private. This is still on the table, but hopefully this will go the way of the Medicines Company/NVS which is from the standard Sarissa playbook.

And BTW, Dr. Denner knows ALZs cold and I suspect he sees value there as well in the hands of a large BP.

The US market was seen as a financial bridge to get Europe started and profitable. Based on Q1 2022 that bridge is now burning, a fact that management hid from everyone including analysts that follow the stock. The Street despises surprises and has no faith in management's ability to execute this plan. What historical evidence do we have of Amarin executing on Vascepa's commercialization?

This brings us to Sarissa and Alex Denner. In some ways this is a perfect storm for them. The science is of course a non-issue and just keeps getting better, and our current plight is Sarissa's raison d'etre. It seems unlikely that they would buy 24 million shares and lose 80% of their investment and just fold their cards. How do they explain that move to their limited partners? They believe in the drug and its enormous potential or else they would not have opened a position. I suspect they also think that the BOD and management need a major overhaul and costs need to be cut drastically in the US, which KM has little experience with and is probably way over his head with a useless BOD to help him.

Like us, they were likely blindsided this week and were probably tied up with Biogen. Now they have to focus and that means starting to aggressively explore BP's interest in Vascepa, and rebuilding financial models based on current US pricing.

Not that many of us would be happy with a BO of $5-6, but from Sarissa's standpoint if they start accumulating shares at $1.50 and flip Amarin in year or two they have done extremely well in a very difficult biotech market.

Time will tell.

Is anyone making money, generics or Amarin? Looking at the RXs, it is very clear that the total pie is not growing in the US nor will it in the near future. (Lovaza gets plenty of new scripts which should be malpractice at this point). Despite pristine science and significant journal publications MDs are not writing the RXs and Vascepa is not selling itself. The generic playbook requires a large mature stable market, and that is the polar opposite of what we have. Add in the potential risk of successful infringement litigation and so far the Du ruling was a pyrrhic victory for the generics. None of them can use economies of scale to decrease their production costs.

It begs the question of can a settlement be reached between Amarin and the generics that would be mutually beneficial?

A real pharma company would at least do a pilot trial on this:

https://www.bmj.com/company/newsroom/diet-rich-in-omega-3-fatty-acids-may-help-reduce-headaches/

Well stated. The combo pill should have been in development and ready for primetime. One more major fail for management. Zip is correct that it will bring brand awareness to Vascepa and rescue the US while litigation drags on. Amarin is once again delusional if they think that they can bring this to market with a GIA strategy. KM is a Europe specialist and needs to focus and stay in that lane. At the very least a joint venture with a BP for R&D, sales and marketing, needs to inked now or else the combo pill will be a cash black hole that will destroy what is left of shareholder value.

I think Sarissa knows this, we will see.

Vascepa should be used for CV prophylaxis immediately post-COVID.

When you consider the number of individuals infected we are talking a million or more significant excess CV events in the US. Vascepa could likely prevent many of them. Hopefully this fact is not lost on Dr. Denner and Pfizer/NVS.

The first comprehensive assessment of the cardiovascular complications of #LongCovid at 1 year, just published @NatureMedicine https://t.co/bCXl6MVPGy
by @zalaly and colleagues @WUSTLmed pic.twitter.com/FD4YRiA5es

— Eric Topol (@EricTopol) February 7, 2022

OT: Kodiak is a "me too" drug. Yes, it will be approved and have decent data. No, it will not dominate the entire retina space as the market will become fragmented. Nobody will switch legacy Eylea patients if they are doing well. Genentech's approval this weekend is a broad label and will also take part of the pie. If there is even a hint of safety issues Kodiak's drug will suffer the same fate as NVS/Beovu.

The current valuation is not going to be consistent with their future market share.

Just MHO

Amarin de-risked.

In biotech investing there are two principle risks 1)the science fails 2) management fails. Anybody looking at #1 at this point with Reduce-it, Jelis, Evaporate, cardiolink, and other smaller studies and case reports would conclude that the science is sound. Amarin has done a truly pathetic job at countering the mineral oil conspiracy charlatans (Nissen). CBB is correct that if Vascepa was owned by a big pharma this issue would not exist. Another failure is that this drug should almost be in the water supply, and at the least standard of care for every at risk cardiac patient. The potential of Vascepa for CAD and where we are now is costing lives on a daily basis. That moral argument may be meaningless to the Street, but I suspect many on this board share that sentiment.

The SP is where it is due to multiple management missteps that for the most part predate KM. Legal strategy has been a disaster and JT can be rightfully faulted for literally betting the company on one judge's opinion. The company had no Plan-b for the US Market if patent protection was lost. Deals with Apotex and Teva all assumed the patents would hold, they did not. Amarin still has no plan-b despite slowly eroding prescriptions. KM is a young, inexperienced CEO and has said that he needs time, for many reasons, not the least is the melting ice cube of value, that is not realistic and is a serious miscalculation on his part. His strategy of grinding it out in Europe and digital outreach in the US has zero chance of success, and the nobody believes the company can execute based on past performance.

Enter Sarissa. They see the potential of this drug in competent hands. Alex Denner knows that he can both profit significantly and better many lives by taking the helm of Amarin. By doing so, the days of GIA delusions of grandeur, and a useless, disconnected BOD are now over. Strategically going forward, Amarin can no longer do something that will further erode SP such as an acquisition or capital raise.

Sarissa certainly has its work cut out for it, but IMO Amarin is now totally de-risked.

Your points are well taken. I think they could structure a deal with a BP such that the could have a floor (say now) and divide any sales beyond the floor. They have essentially admitted they cannot grow US market share with the huge headwinds against them. I doubt they could have done it anyway based on past performance.

Partner the US, gain brand recognition, do combo pill with partner, management can then focus on Europe grind.

SP goes up, and KM might even get some institutional love from the Street. This is what our activists must push for.

Business as usual will just be a dismal cycle of more of the same.

Here is a 30,000 ft view of the issues and possible solutions for Amarin:

1) Europe and ROW- this is what KM was originally brought in to do and what he has a track record on. By any reasonable analysis this is going to be a multi-year process and a very slow grind. The Street gives near zero value for this which is a reflection of Amarin’s horrendous track record in building market share in the US, opportunity or not, they have no credibility when it comes to execution. The China delay further hurt management credibility when they were guiding for end of ’21. Amarin is now at the mercy of multiple national regulatory entities in terms of approvals and pricing. Zero value….no, but hard to be very optimistic in near term.

Nothing more to say here, other than management cannot counter bearish perception unless real numbers start coming in.

2) US Market- This is almost the reverse of Europe, and we are seeing a war of attrition with multiple generics now in the market. Amarin’s only protection which is API control is slowly beginning to crumble and that will continue in the near and long term. Their paralysis and failure to recognize this is a serious management flaw and should be addressed at the board level.

There are several possible ways to reverse this going forward:

A) Authorized Generic- management has said repeatedly that they do not want to take this step as it will impact US profits. This may be truthful in the short term, but it seems likely with the continued erosion of a small poorly developed market, doing nothing to increase prescriptions will be a poor strategy. Amarin claims that they control the majority of world’s API for producing icosapent ethyl. By that logic, they should be able to produce Vascepa far cheaper than their generic competition. The trade off of profit for market share needs to be carefully analyzed and it is conceivable that with so many generic players in the market, an Amarin authorized generic will simply make it unprofitable for each generic to compete. An AG would also be viewed as a positive step by the Street as it shows management is willing to address the dismal cycle of prescription losses that now exists.

B) Partner the US Distribution of Vascepa with a large pharma- Undoubtedly this strategy would significantly move the share price up, as the Market values the US at near zero and a joint venture would create BO excitement. Despite stellar science, a massive ineffectual salesforce, and direct to consumer advertising, Amarin has barely made any penetration in the CV market. This fact is not in dispute. The Pfizer/HLS deal in Canada should now be able to provide a bellwether of the marketing advantages of a joint venture with a large pharma invested in the CV space. By anecdotal reports this deal has been positive and profitable. Partnering the US would also leave management to grind it out in Europe and build value if they can.

C) Combination Pill- It is inconceivable why Amarin just finally reached this conclusion and lost years of development time. As a pure CV play there can be no doubt that the existence of this product could be a several billion dollar drug in the right hands. Amarin has significantly undervalued the importance of a one pill solution for patient compliance and ease of prescribing. Hypothetically, “Vascepator (sounds like a dinosaur)” could be marketed as a turbocharged Statin that capitalizes on the brand recognition of Lipitor and the power of Pfizer. From Pfizer’s standpoint I believe there are significant patent implications for Lipitor and this would allow them to recapture what for years was a massive profit generator.

The complexity of creating this product, getting it rapidly through the FDA, and marketing it is well beyond Amarin’s capability. We have no evidence that supports GIA, as to date that has been utterly futile, and announcing that would be met with derision by the Street.

A positive strategy would be combining option B and C and let Amarin focus on Europe and ROW. This seismic shift would instantly change institutional perception of the company and give management some much needed credibility. A BP partnership would also allow the bandwidth for the company to begin serious well designed trials in Alzheimers, post chemo, Long COVID, and multiple other indications that Amarin’s method of action may be applicable for. This is not currently possible as the recent COVID trials in Argentina showed and failed due to under powering and poor design. Management has forgotten that Amarin is a one product company, but that one product has broad applicability in multiple major diseases. That future value has also been discounted to zero by market perception.

Legal- Potentially critical but I prefer not opine as I don't have the expertise to say anything useful.

Alex Denner/Sarissa is on Biogen's BOD. It is probably already on their radar screen. CBB watch our activists carefully, hopefully they will help KM navigate out of Amarin's current mess. They know the science and potential, we just need leadership that can execute and is not indifferent to Amarin's shareholders.

Vascepa may very well be an Alz drug.

Amarin now has its US strategy made crystal clear 1) Create authorized generic to accommodate states that demand generic substitution. 2) negotiate contracts with each major insurance co. 3)If a payor will not play ball sue them. No insurance carrier is going to risk prolonged litigation and potential treble damages because they don't want to pay a minor difference for a drug that still has limited patient usage. Hikma actually lost today and it will take the Street a day or two to figure it out. KM needs to articulate a new US strategy, our activists will help him, and the US market is now back in play. Amarin needs to EXECUTE.

Paging Steve Ketchum and KM. Pick up the phone and call Pfizer/NVS/Gilead, whichever is on speed dial. Now pretend you are a small biotech that has an incredible drug but does not have the bandwidth to do important studies without BP partnership.

Hmmm, unmet need, millions of patients worldwide, MOA that is consistent with your one product. It might even move your SP.

From Bloomberg Today:

Long Covid Patients Face Fatigue, Poor Sleep Even After One Year
Over 70% didn’t fully recover 12 months after hospitalization
Patients who had severe Covid fared worse in U.K. study
A health professional helps a Covid-19 patient exercise at the Intensive Care Unit of the Virgen de Fatima contingency hospital, in Peru.
A health professional helps a Covid-19 patient exercise at the Intensive Care Unit of the Virgen de Fatima contingency hospital, in Peru.Photographer: Ernesto Benavides/AFP/Getty Images
ByIrina Anghel
December 15, 2021, 7:01 PM EST
Listen to this article
2:22
@irinaanghel12
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In this article
0235987D
UNIVERSITY OF LEICESTER
Private Company
Tracking Covid-19
736,?191
New cases reported worldwide, Dec. 15
5,?330,?556
Total deaths reported worldwide
U.S.
141,205
Most new cases today
8,?563,?904,?063
Vaccine doses administered in 184 countries
+32%
Change in MSCI World Index of global stocks since Jan. 23, 2020
-0.?2777
Change in U.S. treasury bond yield since Jan. 23, 2020
Open
Most people hospitalized with Covid-19 who emerged with lingering symptoms from the infection showed little improvement a year later, according to a study seeking to assess the effect of long Covid.

About seven in 10 Covid long haulers continued to face symptoms like fatigue, muscle pain, lack of sleep and breathing difficulties 12 months after hospital discharge, a study led by the U.K.’s National Institute of Health Research found. There was no or very little improvement compared with seven months earlier.

Researchers are working to better understand long Covid and its ramifications amid concern that a growing number of patients with persistent symptoms will strain labor markets and health systems for years to come.

“When you consider that over half a million people in the U.K. have been admitted to hospital as a result of Covid-19, we are talking about a sizable population at risk of persistent ill-health and reduced quality of life,” said Chris Brightling, senior investigator at the institute and professor of respiratory medicine at the University of Leicester.

The study looked at 2,320 adults across the U.K. who had been hospitalized with the disease. All participants were tested five months after being released from the hospital, and about a third returned for the one-year assessment so far.

People with the most severe forms of long Covid reported a higher number of after-effects compared to those with milder symptoms. The evidence also confirmed that those who are female, obese and needed mechanical breathing assistance during their hospital stay were less likely to fully recover.

Brain Fog
The study may also lead to new ways of tackling the problem, some of the scientists said. They found higher levels of substances indicating whole-body inflammation and molecules linked with tissue damage in patients with the most severe forms of long Covid. These participants also showed a pattern of brain fog -- memory and attention problems, and a decrease in their ability to initiate action.

“The good news is that we have identified some differences in the blood samples of those who are still experiencing the long-term physical and cognitive effects of their Covid-19 hospital admission,” said Louise Wain, one of the paper’s lead authors and GSK/British Lung Foundation chair in respiratory research at the University of Leicester. “These differences give us clues about the potential underlying mechanisms.”

The results, part of a cohort study launched in the summer of 2020 that tracks Covid patients after they leave the hospital, have not yet been reviewed by other researchers.

Aside from being under powered, Prepare-it was studying a population that is not comparable to obesity in the United States. This is likely why Statins and Vascepa are showing a clinical signal for COVID. The results are applicable to other viral infections as the article mentions. If only Amarin had the resources to run a real study on this...

https://www.nytimes.com/2021/12/08/health/covid-fat-obesity.html

No idea if it works, this study was intriguing. At the very least you sleep better.
https://health.clevelandclinic.org/can-melatonin-help-treat-covid-19/

It may prevent the progression to wet AMD from dry AMD. Huge correlation with CAD and wet AMD. Once you have wet AMD there are of course efficacious treatments.

All the biomarkers that Vascepa is known to decrease have been associated with Macular Degeneration (hCRP especially). Someone just needs to do the study which suffice to say Amarin is in no position to do at this point. No question IMO that Vascepa would be a useful treatment for severe diabetic retinopathy. These are all diseases of the mircovascularture. It is a logical extrapolation from CVD and peripheral artery disease, and I also think ALZ is a microvascular disease and not really caused by amyloid. This is the untapped potential that will get attention when hopefully a BP acquires Amarin.

CBB. With BVF and Sarissa now holding significant shares Amarin's future prospects have brightened significantly. I would suggest looking carefully at Dr. Denner's investment and personal history. His doctorate at Yale was in the cardiac space, and Sarissa's second in command is an internist by training. THEY UNDERSTAND VASCEPA's POTENTIAL. Sarissa also knows ALZ cold given their position in Biogen. They have a substantial holding in Gilead, and their last acquisition play was with NVS. All of this bodes well for the future.

Hmmmm....can anyone think of a drug that significantly reduces the risk of CVD and stroke, and has a better side effect profile than aspirin? I wonder if such a drug exists?

https://www.nytimes.com/2021/10/12/health/aspirin-heart-attack-stroke.html

I am assuming (caveat:big intuitive leap) that statins may be exerting the observed clinical effect by their overall anti-inflammatory action. We see this in COVID where both drugs apparently have efficacy. The article is unclear on MOA, so this is conjecture on my part.

Indirect evidence for Vascepa efficacy for oncology indications:

Pfizer, you out there?

https://www.healio.com/news/hematology-oncology/20210915/statins-may-extend-survival-for-certain-women-with-triplenegative-breast-cancer?utm_source=selligent&utm_medium=email&utm_campaign=news&M_BT=90267668279

Not so complicated. Create the combo pill around two of the most common doses used. Layer on another statin pill for higher, uncommon dosing. We do this all the time. You could even just take more of the combo pill as 8 gms/day of Vascepa seems to be perfectly safe.

CBB Pfizer could reboot Lipitor by marketing a combo pill. I actually think that is their endgame and is enormously valuable.

A combo pill would really put the generics in a strategic box, especially after Teva/GSK. No skinny label justification, as it is CVD specific and would be crystal clear infringement. Much easier for MDs to prescribe and no insurance company will demand a patient take their statin and fill a separate RX for generic-V

This drug would "actually sell itself robustly." ??. It will also save countless lives.

KM knows this too.

Another reason why Vascepa is needed for COVID
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00896-5/fulltext

Hard to imagine that this is a random outcome. Chest X-rays are not subjective. And yes, it is only a case report publication, but it is intriguing and may foreshadow what is coming.
https://www.amjcaserep.com/abstract/index/idArt/928422

I am somewhat confident that Vascepa will be efficacious for COVID. It reminds me of Reduce-it, which had multiple studies pointing to the overall stunning result that Vascepa could prevent severe CV events. COVID is a disease of blood vessels, and we know that Vascepa is highly protective of endothelial cells (lining of blood vessels). The question still remains if Amarin can get traction for an inexpensive COVID treatment with no side effects. In theory a blister pack of Vascepa could be given to every patient that has early COVID symptoms. It remains to be seen if Amarin can execute, and get the world a vital life saving drug.

Raw material limitations for Vascepa? Does anyone have insight into the question of raw material for Vascepa. Is there a point where demand may surpass natural supply? Not a problem today, but possible if/when COVID/ALZ data shows utility. This of course assumes Amarin executes.

I am sure at this point the company has been told not to discuss the supply chain in anyway given litigation and antitrust issues.

Question for Legal Eagles. Assuming judge rules that a trial is appropriate, if you are advising Hikma/HealthNet would you strongly advise settlement? Downside risk is hugely asymmetric due to treble damages and for HealthNet this is clearly not their fight. For Hikma, you can't get supply cheaply, you can't encapsulate the drug correctly, and you can barely sell it because the market is so immature. What responsible CEO is going to fight over ashes and risk their job and Company? GV is never going to be a blockbuster for them no matter what they do. Patents are not the only way to protect exclusivity. De Beer's maintained a monopoly and set diamond prices for decades by controlling supply of a finite commodity.

What is the Plan when COVID data is Positive? For many reasons I strongly suspect that both the Kaiser and Argentina COVID studies will be positive. My question for KM is what is the plan when you get that data? Is this going to be like Reduce-It where millions don't receive a lifesaving drug despite unassailable data that shows enormous efficacy. Amarin will need to hit the ground running with a powerful PR campaign and quickly navigate regulatory agencies to get Vascepa to COVID patients. Can they do it, or will this be another tree falling in the forest?

Someone will one day. It is a vital multibillion dollar market which will only increase with an aging population.

I could not even get insurance to authorize Vascepa for my severe diabetics with high trigs.

I am afraid not. Retinal detachment is a mechanical issue much like wallpaper peeling off a wall.

Conceivably by mitigating inflammation it may slow nerve cell damage. We don't know yet and the mechanism is prominent in ALZ, so someone needs to find out.

I had a discussion with Steve Ketchum at Amarin on this very subject. I also reached out to the national eye institute. Macular degeneration is characterized by many of the same biomarkers that Vascepa decreases in CVD. It is also though to be an inflammatory disease of small vessels. It will work, but someone needs to prove it.

26

Vascepa for Long Covid and loss of smell?
https://www.nytimes.com/2021/01/02/health/coronavirus-smell-taste.html

Note last paragraph that fish oil is being studied. Mechanistically this makes sense. Another study for Amarin to do and publicize... it won't happen.

Ignore double post by me

I sure would not want to be the one to tap dance on stage for 45 minutes to describe a negative study. They clearly saw something or what is the point about talking about MOA for COVID?